Sr. Regulatory Operations Specialist
PRIMARY OBJECTIVE OF THE POSITION:
The primary duties of this position are to compile, publish and submit eCTD compliant regulatory dossiers to the FDA and other health authorities in a timely manner, and provide Regulatory support to project teams.
MAJOR RESPONSIBILITIES AND DUTIES:
• Plan, compile, publish and submit Regulatory documents for IND, NDA, BLA, IDE, and PMA applications, including Amendments, Supplements, and Meeting materials to the FDA.
• Review submission components for quality and completeness.
• Assure all electronic submissions are in compliance with regulatory requirements and ICH eCTD specifications.
• Maintain Regulatory submission and correspondence archive/records.
• Provide publishing support to the Medical Writing group, as requested.
• Provide regulatory support to other departments, as requested.
• Assist Regulatory Director in providing regulatory strategy, intelligence, and other regulatory support to product development teams.
• Serve as a point of contact for the FDA.
The candidate should have a BS degree preferably in a scientific discipline (or equivalent knowledge and experience) and a minimum of 3 years’ experience in Regulatory Operations/electronic submissions. Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable.
Good understanding of FDA’s submission requirements and drug/biologic/device development processes is required. Good oral and written communication skills, detail-oriented, self-directing, and ability to handle multiple projects across all functional areas independently are essential.